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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K191760
Device Name PICO 14 Single Use Negative Pressure Wound Therapy System
Applicant
Smith & Nephew Medical Limited
101 Hessle Road
hull,  GB hu3 2bn
Applicant Contact sam greenhalgh
Correspondent
Smith & Nephew Medical Limited
101 Hessle Road
hull,  GB hu3 2bn
Correspondent Contact sam greenhalgh
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/01/2019
Decision Date 12/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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